SPECTROLYSE/FIBRIN— 510(k) K881037

Substantially Equivalent

Cytrx Biopool, Ltd.

FDA 510(k) clearance K881037 for SPECTROLYSE/FIBRIN, Substantially Equivalent on 1988-07-01. Applicant: Cytrx Biopool, Ltd.. Device class: 2.

Clearance details

Applicant: Cytrx Biopool, Ltd.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1988-03-11
Decision date: 1988-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGP

K251440 — CRYOcheck Chromogenic Factor VIII2025-08-25
K230852 — HemosIL Chromogenic Factor IX2023-12-13
K220728 — vWF Ag2023-06-02
K214002 — CRYOcheck Chromogenic Factor IX2022-12-23
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.